25 January 2010
ByAppeared in BioNews 542
The UK's Human Fertilisation Authority (HFEA) has for the first time released internal documents from an investigation. These reveal the fertility watchdog's findings about two IVF Grade A incidents at Guy's and St Thomas' NHS Trust. In one, the wrong patient's sperm were used for micro-injection, although none of these eggs were allowed to proceed to fertilisation, and the patients involved were informed immediately; and in the other, four embryos were rendered unusable following PGD (preimplantation genetic diagnosis) treatment as the wrong patient's sperm had been used in the fertilisation process. An HFEA Representations Hearing, which took place on 14 December 2009, found that due to positive actions the centre had taken to resolve major concerns, there was no need to vary the centre's licence to practice.
Alan Doran, Chief Executive of the HFEA, said: 'Serious incidents in the fertility sector are rare but they do happen. When they do, everybody involved - patients, the centre, the public - wants us to make sure that we understand why they happened. That is why we investigate them thoroughly, as has happened with the incidents at Guy's ACU. By releasing these documents, we are being transparent about how we go about this important work. We owe it to people using fertility services to ensure that those services are of the best quality. We will continue to work with fertility clinics to improve services, to reduce risk and to build on best practice'.
The Representations Hearing was convened to consider the decision made by the Licensing Committee on 21 September to vary the centre's licence by imposing additional conditions to it. First, that the centre must not process more than one patient sample in a designated work area at any one time. Second, that the legal 'Person Responsible' (PR) at the clinic, Mr Yakoub Khalaf, must implement and audit the action plan (which the centre had provided) in August 2009, and provide a report to the authority on the outcome by 1 April 2010; and third, that the PR must ensure that staff are trained to meet the requirements of the action plan and must submit details of the training provided as part of a report to the authority. At the hearing it was noted that the clinic had already taken steps to address these recommendations. First, by moving to new premises, which include two distinct work areas for processing samples and, second, by ensuring that the PR had completed the Person Responsible Entry Programme for the 8th Code of Practice. Furthermore, the clinic had installed an electronic witnessing system, which sounds an alarm if more than one sample is in the processing area at the same time. All staff had been trained to use this new system and received instruction about how to carry out manual witnessing, should the electronic system fail.
It was also noted, having examined a full set of inspection reports that, although issues regarding witnessing and processing of more than one patient's sample in the same work area had been raised, the centre's practices had not been categorised as breaches and recommendations had been followed up promptly. The centre had not been given a clear direction from the HFEA, following two inspections, to stop processing more than one sample at once in the same work area.
An HFEA re-inspection carried out in November 2009 by Dr Andrew Leonard agreed that the clinic had taken appropriate action following the allegations against it and that the proposed variation to its licence to practice were no longer necessary. The only outstanding area of concern noted during this inspection was the partial validation of the electronic witnessing system, an area which the HFEA committee has asked to be addressed, despite acknowledging that this is only 'a minor issue'. This has since been completed by the centre.
The committee decided that there was no evidence that the PR Yakoub Khalaf had failed to discharge his statutory duty as a PR.